BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE PFS

    MDR report key: 24616979 · Received March 17, 2026

    Report

    Report Number
    MW5185282
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Report Date
    March 11, 2026
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    UDI-DI
    58468009003
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6). MEDICAL ASSISTANT REPORTED THAT THE SYRINGE COVER WAS NOT COMPLETELY SCREWED IN AND THE MD DOES NOT FEEL COMFORTABLE INJECTING. MISSED DOSE REPORTED. NO ADVERSE EVENT REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. DIAGNOSIS FOR USE: OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684492 SYNVISC ONE PFS ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION FRSLB34Z 58468009003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male